The following data is part of a premarket notification filed by Radiadyne with the FDA for Oartrac System.
Device ID | K141154 |
510k Number | K141154 |
Device Name: | OARTRAC SYSTEM |
Classification | Dosimeter, Ionizing Radiation, Implanted |
Applicant | RADIADYNE 816 CONGRESS AVE. SUITE 1400 Austin, TX 78701 |
Contact | Stuart R Goldman |
Correspondent | Stuart R Goldman RADIADYNE 816 CONGRESS AVE. SUITE 1400 Austin, TX 78701 |
Product Code | NZT |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-05-05 |
Decision Date | 2014-07-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00851546007097 | K141154 | 000 |
00851546007080 | K141154 | 000 |
20851546007060 | K141154 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
OARTRAC SYSTEM 85058933 not registered Dead/Abandoned |
Radiadyne, LLC 2010-06-09 |